Clinical trial · Interventional
Tumour Localisation With Magnetic Clip Before Neoadjuvant Chemotherapy.
Tumour Localisation With Magnetic Clip Before Neoadjuvant Chemotherapy. A Randomised Pilot Feasibility Study: MagLocal 1.0
NCT06463600CI-TRIAL-00078041MagLocalunknownN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The feasibility of the use of magnetic clips for tumour localisation before preoperative chemotherapy in combination with superparamagnetic iron oxide nanoparticles (SPIO) as tracer for sentinel lymph node (SLN) detection and in combination with a magnetic clip in the index lymph node metastasis is studied.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Conserving Surgery | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Magseed | Device | — | UNRESOLVED |
| Metallic clip and guide wire | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Tumour localisation with Magseed
- description
- Before preoperative chemotherapy a Magseed is inserted in the breast tumour
- interventionNames
- Device: Magseed
- type
- ACTIVE_COMPARATOR
- label
- Metallic marker + guide wire
- description
- Before preoperative chemotherapy an ordinary metallic clip is inserted in the breast tumour. Before surgery a guide wire is inserted to localise the clip.
- interventionNames
- Device: Metallic clip and guide wire
Primary outcomes (1)
- measure
- Specimen volume
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age above 18 years 2. Planned for preoperative chemotherapy before breast cancer surgery 3. Planned breast conserving surgery with targeted axillary dissection or sentinel lymph node biopsy using magnetic technique 4. SLN-biopsy with magnetic tracer or targeted axillary dissection using magnetic tracer and Magseed 5. Signed and dated written informed consent before the start of specific protocol procedures Exclusion Criteria: 1. Pregnant or breast-feeding 2. Iron overload disease 3. Known hypersensitivity to iron or dextran compounds 4. Inability to understand given information and give informed consent or undergo study procedures 5. Planned MRI control for tumour response during chemotherapy
References
Publications (0)
Data not yet available
No reference posted for this study.